Multi-morbidity, goal-oriented care and equity.

James Mackenzie lecture 2011.

Prof. J. De Maeseneer, MD, Ph.D., FRCGP (Hon)1, Pauline Boeckxstaens, MD, PhD-student2.

1, 2 Department of Family Medicine and Primary Health Care, International Centre for Primary Health Care and Family Medicine – Ghent University, WHO Collaborating Centre on Primary Health Care.

1, 2 General practitioner, CommunityHealthCenter "Botermarkt", Ledeberg – Gent.

1 Vice-dean Strategic Planning Faculty of Medicine and Health Sciences, GhentUniversity.

1 Chairman European Forum for Primary Care () and Secretary-General The Network: Towards Unity for Health ()

Introduction.

James Mackenzie (°1853) was a famous general practitioner who spent a major part of his practice life in Burnley, an industrial town in the north of England. He was a great clinician with the skill of detailed observation that underpins, even nowadays, any scientific activity. Already in 1907, when opening the Leeds post graduate course, he stressed the central role of the general practitioner in observing and managing chronic disease throughout its course. Hereby, James Mackenzie was probably one of the first to think of epidemiology in terms of non-infectious diseases.

Today it is clear that we face an important demographic and epidemiological transition, confronting us with the challenge of non-communicable diseases (NCDs), which occur more and more in the context of multi-morbidity. In the next decade, multi-morbidity will become the rule, no longer the exception.

We explore the presentation of multi-morbidity in an international context and describe how patients with multi-morbidityare approached today.Wewill argue for the need for a paradigm-shift from problem-oriented to goal-oriented care, which requires new types of evidence and research, and finally wewill try to integrate this development into the perspective of quality and equity in health.

Presentation of multi-morbidity in an international context.

Apart from the deaths caused by infectious diseases, the number of people dying as a result of non-communicable diseases has risen to 36.1 million per year worldwide. This means that for the moment almost 2 of 3 deaths are attributable to NCDs [1]. For adults this is even 3 in 4. NCDs are not merely a problem of the wealthy aged. Most of these deaths arise in the poorest countries (22.4 million) and 63% of premature deaths in adults (age 15-69 years) are attributable to NCDs.

Especially in developed countries, with increasing life expectancy, NCDs are more and more a phenomenon, accompanied by a rise in multimorbidity : 50% of the 65+ have at least 3 chronic conditions, whereas 20% of the 65+ have at least 5 chronic conditions[2]. In the case of COPD e.g. more than half of the patients have at least one comorbid disease[3].

In recent literature, this development is defined as an "NCD-crisis"[4]. However NCDs cannot be regarded as a completely separate problem. In HIV and AIDS several studies [5][6][7] have demonstrated an increased incidence of heart disease, diabetes mellitus, kidney disease, liver disease, osteoporosis, malignancies (other than the well known associated Kaposi’s sarcoma and non-Hodgkin’s lymphoma), and possibly chronic obstructive pulmonary disease[8]when HIV/AIDS patients were compared to age matched HIV-uninfected controls. An observation which clearly creates important challenges for developing countries.

Describing the rising prevalence of NCDs as a "crisis" makes for good drama, but misleads us into thinking that this problem is amenable to a quick fix. NCDs represent a set of chronic conditions, that will require a sustained effort for many decades.

How do we address patients with multi-morbidity today?

In recent years, not only Western countries, but also developing countries started with "chronic disease management-programs" in order to improve care. The design of those programs includes most frequently: strategies for case-finding, protocols describing what should be done and by whom, the importance of information and empowerment of the patient and the definition of process- and outcome-indicators that may contribute to the monitoring of care. Finally, incentives have been defined in order to stimulate both patients and providers to adhere to guidelines. This development has led to spectacular results e.g. in process- and outcome-indicators in the United Kingdom under the Quality and Outcomes Framework[9]. Moreover, the "chronic disease management"-approach has led to an acceleration of the implementation of the subsidiarity-principle in primary health care with important task-shifting from physicians, to nurses, dieticians, health educators,... In spite of some critical reflections with respect to equity[10][11], to the sustainability of the quality improvement, and comprehensiveness versus reductionism[12], in general, these programs have received positive feedback from providers, patients and politicians.

Wagner has described the different components of the Chronic Care Model (CCM) as developed in the context of primary health care[13]. He emphasised the need for changes both at the level of health systems (through health care organisation) and at the community level (through resources and policies) with an emphasis on self-management support, delivery system design changes, and appropriate decision support in the context of clinical information systems. It is hoped that all these changes will lead to productive interactions between an informed, empowered patient and a prepared, pro-active practice team, in order to achieve improved outcomes. The CCM has inspired policy makers and providers all over the world and is widely accepted in North America, Europe and Australia. Taking into account the epidemiological transition, we are faced with the question: "How will this approach work in a situation of multimorbidity?"

Let us illustrate this with a patient from our general practice, we call her "Jennifer".

In box 1I describe the case of Jennifer.

Box 1. Jennifer

Jennifer is 75 years old. Fifteen years ago she lost her husband. She has been a patient at the practice for 15 years now. During these last 15 years she has been through a difficultmedical history: hip replacement surgery for osteoarthritis, hypertension, diabetes type 2, and COPD. She lives independently at home, with some help from her youngest daughter, Elisabeth. I visit her regularly and each time she starts by saying: "Doctor, you must help me". Then follows a succession of complaints and feelings: Sometimes it has to do with her heart, another time with lungs, then the hip,… Each time I suggest – according to the guidelines – all sorts of examinations that do not improve her condition. Her request becomes more and more explicit, my feelings of powerlessness, inadequacy and irritation, increase. Moreover, I have to cope with guidelines that are contradictory: for COPD she sometimes needs corticosteroids, which always worsens her diabetes control. The adaptation of the medication for the blood pressure (once too high, once too low) does notmeet with her approval, and nor does my interest in her HbA1C and lung-function test-results.
After so many contacts, Jennifer says: "Doctor, I want to tell you what really matters tome. On Tuesday and Thursday, I want to visit my friends in the neighbourhood and play cards with them. On Saturday, I want to go the supermarket with my daughter. Foremost, I just want some peace. I do not want to continually change the therapy anymore, especially not having to do this and to do that". In the conversation that followed, it became clear to me how Jennifer had formulated the goals for her life. At the same time I felt challenged to identify how the guidelines could contribute to the achievement of Jennifer's goals. I have visited Jennifer with pleasure ever since. I know what she wants and how much I can (merely) contribute to her life.

According to the actual guidelines, Jennifer is faced with a lot of tasks[14]: joint protection, aerobic exercise, muscle strengthening, a range of motion exercising, self-monitoring of blood glucose, avoiding environmental exposure that might exacerbate COPD, wearing appropriate foot wear, limiting intake of alcohol, maintaining body weight. She has to receive patient education regarding diabetes self-management, foot care, osteoarthritis and COPD medication delivery system training. Her medication schedule includes 11 different drugs, with a total of 20 administrations a day. The clinical tasks for the general practitioner include vaccination, blood pressure control at all clinical visits, evaluation of self-monitoring of blood glucose, foot examination, laboratory tests… Moreover, referrals are needed to physiotherapy, for ophthalmologic examination and pulmonary rehabilitation. So, Jennifer's reaction isnot unexpected.

Jennifer's case clearly illustrates the need for a paradigm-shift for chronic care: from Problem-Oriented to Goal-Oriented Care. In 1991, Mold and Blake[15] recognised that the problem-oriented model, focusing on the eradication of disease and the prevention of death, is not well suited to the management of a number of chronic illnesses. Therefore they proposed a goal-oriented approach that encourages each individual to achieve the highest possible level of health as defined by that individual. This represents a more positive approach to health care, characterised by greater emphasis on individual strengths and resources. Goal-Oriented Care assists an individual in achieving their maximum individual health potential in line with their individually defined goals. The evaluator of success is the patient, not the physician. And, what really matters for patients is their ability to function (functional status), and social participation. So, certainly in the context of multi-morbidity, there is a need for a shift from "Chronic Disease Management" towards "Participatory Patient Management", with the patient at the centre of the process.

Exploring the goals of patients will require new conceptual frameworks, new types of research and new research-designs and -methods. Nowadays, understanding self-determination and self-agency in relation to the disease, is highly valued by patients. For many people, giving meaning to the chronic illness-process they are going through, is of the utmost importance. Safety and avoiding side-effects (not having to suffer more from the treatment than from the disease) is very important. Patients expect comprehensiveness in their care instead of fragmentation.

A recent survey of "chronic disease management" in 10 European countries illustrated that most of the countries chronic disease management programs are organised bythe label of one chronic condition, sometimes focusing on subgroups, within a specific chronic disease[16]. The 5 conditions most frequently addressed are cancer, cardiovascular disease, COPD, depression and diabetes. Most of the programs use a vertical disease-oriented approach. Vertical disease-oriented programs, originated from the concept of "selective primary health care" that developed shortly after the Alma Ata Declaration. The idea was that a selective approach would attack the most severe public health problems facing a community in order to have the greatest chance to improve both health and medical care, especially in less developed countries[17]. Although much has been learnt from vertical disease-oriented programs, evidence suggests that better outcomes occur by addressing diseases through an integrated approach in a strong primary care system. An example is Brazil, where therapeutic coverage for HIV/aids reaches almost 100% which is much better than HIV/aids programs in other countries with less robust primary care[18]. Vertical disease oriented programs for HIV/AIDS, malaria, tuberculosis and other infectious diseases foster duplication and the inefficient use of resources, produce gaps in the care of patients with multi-morbidity, and reduce, especially in developing countries, government capacity by pulling the best health care workers out of the public health sector to focus on single diseases[19]. Moreover, vertical programmes cause inequity for patients who do not have the “right” disease[20]. Horizontal primary care provides the opportunity for integration and addresses the problem of inequity, providing access to the care of all health problems, thereby avoiding "inequity by disease[21].

Need for new types of evidence: medical, contextual and policy evidence.

Clinical decisions must be based on adequate knowledge of diseases (medical evidence) but at the same time, they must take into account patient-specific aspects of medical care (contextual evidence) and efficiency, equity and rationing (policy evidence)[22]. As far as medical evidence is concerned, within primary health care, we are confronted with the tension between the results of clinical research on the one hand and the needs of daily clinical practice on the other hand. The available research generally does not include a representative sample of patients with respect to age and ethnic origin or comorbidity, and does not take into account the typical non-specific presentation of symptoms atan early disease stage. As the case of Jennifer (see box 1) illustrates, within primary care, questions arise onwhich evidence to follow in the case of multimorbidity. Treatment according to the guidelines forone condition (corticosteroids for COPD) may interfere with the guidelines for another disease (glycemic control in diabetes type 2). There is a lot of evidence available on the treatment ofCOPD or the management of type 2 diabetes for patients younger than 75 yearsbut there is little, if any, evidence about how to treat a 75-year old woman who has both or even additional disorders. This problem implies a need for research on the effectiveness of diagnostic and therapeutic interventions that take into account these aspects of patients in primary care. The challengeofmulti-morbidity illustrates the lackof appropriate evidence. A basic assumption in the development of guidelines is that clinical research follows clinical relevance. In reality, a lot of research is driven by commercial interests[23]. A consequence is that the focus has shifted from "treat-the-patient" towards "treat-to-target". And in achieving the "target" much more evidence is available for pharmacological treatments than on the effects of interventions aimed at changing health behaviours. So, the threat in Evidence Based Medicine is pursuing what is possible and available, rather than what is relevant.

If we want to take the goals of the patient into account, we need a new type of evidence: contextual evidence, to assist doctors inaddressing the challenge of how to treat a particular patient in a specific situation. Contextual evidence deals with the principles of good doctor-patient communication in order to create trust in the interpersonal relationships, the exchange of pertinent information, exploration of the goals of the patient, and negotiation of treatment-related decisions. Communication training fordoctors is only part of the story. Other factors that affect communication are related to the character and personality of both doctor and patient and their personal history (continuity of care), disease characteristics (life-threatening diseases, depression, chronic pain), actual goals in a specific life-cycle and family, socio-economic and cultural circumstances.

It is difficult to imagine how exploration of the case of an individual patient may be reconciled with the need forthe rigorous standardisation of a clinical encounter as required by the Randomised Controlled Trial. Another problem with RCTs is the design-related exclusion (e.g. patients with comorbidity) and the selective study dropout: patients from lower socio-economic status – in itself a barrier to implementation of certain diagnostic and therapeutic strategies – might most frequently be lost to follow-up.

Translation from research to practice presumes that patients are open to a "rational approach", take responsibility for their own health, and make their own informed decisions. Evidence Based Medicine depends in part on these factors, but many patients attribute their health status to external factors beyond their control (external health locus of control)[24]. Where research offers probabilities and numbers needed to treat, patients expect certainty from their physician, wanting to know whether the treatment will besuccessful for them. So, understanding contextual evidence is essential to bridging the gap between efficacy (what works in isolation and in an ideal setting) and effectiveness (what works in routine practice).

In order to better understand the goals of the patients, new research frameworks and research-disciplines will be needed. This will require input from disciplines that contribute to the understanding of provider-patient interaction such as medical philosophy, sociology and anthropology. Research methods will have to shift from purely quantitative (RCT) towards qualitative approaches (focusing on understanding through in-depth-interviews, focus groups, …). We will have to look for research-tools and approaches that focus on subjective determinants of well-being, and not only at biomedical parameters. In the new research-designs, patients with multi-morbidity will be the rule (instead of an exclusion criterion) and complexity will be embraced instead of avoided[25].The International Classification of Function (ICF)[26] might become as important as the International Classification of Diseases (ICD), as it provides a conceptual framework in which different domains of human functioning are defined. These domains are classified from an eco-bio-psycho-social viewpoint by means of a list of body functions and structures, and a list of domains of activity and participation. As an individual’s functioning and disability involves a context, the ICF includes a list of environmental factors and the concept of personal factors in its framework. The ICF is part of the “Family of International Classifications” (FIC) and meets the standards for health related classifications as defined by the WHO. Although the ICD has a dominating role in health care data management, the WHO aims to reach the same level with the ICF, a classification that is able to define functional status, irrespective of the underlying health condition.